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MIXJECT 9070115Recalls & reported problems

West Pharma. Services Il, . Ltd · Mixject 13mm SIL w/30G Needle · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290108241044), received between Jul 21, 2023 and Jul 21, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incomplete or Missing Packaging” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Incomplete or Missing Packaging1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 21, 2023Incomplete or Missing Packaging; Incomplete or Missing Packaging

    THE CUSTOMER, (B)(6), CONTACTED WEST PHARMA SERVICES, IL LTD (WEST IL) ON (B)(6) 2023 TO REPORT THAT DURING IN-PROCESS INSPECTION AND PRIOR TO USE OF THE MIXJECT 13MM FTH RIBS 30G, LOT F575, FIVE UNITS WERE DISCOVERED TO BE MISSING THE TYVEK SEALING FOIL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17373410 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.